Abstract

Research ObjectiveThe past decade has seen a proliferation of pragmatic clinical trials (PCTs) conducted in health care delivery settings. PCTs can be more informative to patients and other decision makers than traditional randomized clinical trials, but also require some level of involvement by provider organizations and health care professionals. However, PCTs have encountered challenges to engaging practicing clinicians. Empirical evidence regarding the views of health care providers on their potential role in such research is lacking, and there is limited information on the best strategies for involving practicing clinicians in PCTs. We conducted a qualitative study to better understand clinician views on their potential role in research conducted in the context of health care delivery and to develop guidance for researchers seeking to partner with clinicians.Study DesignWe conducted focus groups with “front‐line” clinicians within five health care delivery organizations. In addition, we conducted key informant interviews with research team members and clinicians participating in the ADAPTABLE aspirin‐dosing trial.Population StudiedThirty‐four health care providers participated in 6 focus groups and 2 phone interviews. Participants included 14 physicians, 8 nurses, 3 mental health providers, 2 dentists, and 7 medical assistants.We conducted 18 phone interviews with ADAPTABLE team members and clinicians, including 5 principal investigators, 10 project managers, and 3 participating clinicians.Principal FindingsFocus group participants strongly emphasized the importance of engaging practicing clinicians early in research planning in order to 1) identify study questions relevant to clinical practice, 2) improve study design with clinical insight, 3) better understand the specific patient population of interest, 4) adapt study protocols to the realities of clinic workflows, and 5) garner provider support prior to study implementation. They were generally supportive of efforts to design PCTs that limit the burden placed on clinicians (“low‐touch” PCTs), but expressed caution regarding the following: reliance on purely electronic approaches to patient engagement, patient hesitation to agree to study participation without checking with their provider, and clinician resistance to anything that might interfere with patient‐provider trust.ADAPTABLE study team members were sometimes surprised by the proportion of patients who wanted to speak with their physician before making a decision about study participation. They described multiple attempts at developing strategies to maximize the likelihood that patients and providers would discuss the study during clinic visits. Factors leading to success included multi‐faceted approaches to reminding both eligible patients and their providers prior to the patient‐clinician interaction and carefully selected and trained research staff.ConclusionsEven for “low‐touch” PCTs, researchers should not underestimate the importance of engaging with front‐line clinicians and clinic staff. We propose a framework for clinician engagement in “medium‐touch” PCTs that recognizes the importance of the clinician‐patient relationship and optimizes the role clinicians play in reassuring patients regarding trial participation.Implications for Policy or PracticePCTs hold the promise of dramatically improving the relevance of clinical trial evidence for decision‐making by patients, clinicians, and policymakers. To fully realize this potential, it is critical that researchers and clinicians find effective and mutually beneficial ways of partnering. Our findings will help to support this important and growing field.Primary Funding SourcePatient‐Centered Outcomes Research Institute.

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